This invention lies in the field of physiological stimulus systems, e.g. pacemaker systems, and in particular implantable systems for physiological stimulation and detection of the response evoked by stimulation.
For the operation of conventional demand type pacemakers, it is necessary to sense the natural QRS signals which are developed in the ventricle, so as to cause resetting of the pacemaker oscillator. The state of the art permits reliable sensing of the natural QRS signal, as is seen from the widespread use of demand pacers. It is noted that, in demand pacer operation, the QRS signal occurs at least a full heartbeat period following the last stimulus pulse, if any, such that conditions in the vicinity of the electrode are relatively quiescent. By contrast, immediately after delivery of a negative going stimulus pulse, there is a large polarization signal present at the electrode, due to the condition of the adjacent heart tissue cells and the effective capacitance of the electrode itself. Since it takes some time for this polarization signal to dissipate it has the effect of masking signals which occur shortly thereafter, e.g., the evoked QRS or evoked T wave signals.
The area of threshold tracking pacemakers best illustrates the problem generated due to the polarization signal at the electrode following delivery of a stimulus pulse. A threshold tracking system is illustrated in U.S. Pat. No. 3,920,024, incorporated herein by reference. To date, there has been no significant commercial use of the implantable threshold tracking pacer, primarily due to the difficulty of detecting the resulting evoked signal in the midst of the polarization signal. Threshold tracking pacers are discussed at length in the literature, and there has been a limited use of external threshold tracking pacers, for various clinical applications. However, they have not achieved the prominence that was predicted some years back, due to the essentially unsolved problem of reliably and accurately picking the evoked QRS signal out of the overall signal which is present at the electrode shortly after delivery of the stimulus. It is clear that the inability to accurately and reliably sense the presence or absence of an evoked heartbeat is critical to the performance of a threshold tracking pacemaker.
The advantage of the threshold tracking pacemaker has been questioned recently, due to the greatly increased power capacity of the lithium battery as compared to prior mercury zinc batteries. The threshold tracking pacemaker would save a considerable amount of energy, and thereby extend pacer lifetime substantially, due to the fact that stimulus pulses would be delivered at or near threshold, instead of at a level which provided a safety factor of 2 or 3 times. Since present day lithium batteries extend the pacer lifetime to 12 to 15 years, this foreseen relative advantage of the threshold tracking pacemaker is greatly attenuated. However, other developments which are foreseeable continue to make it desirable to achieve a solution which would permit a reliable threshold tracking pacemaker. The ability to monitor threshold and to process information obtained from the evoked heartbeat may be quite useful in future pacemaker models, such as for providing a diagnostic aid in determining patient condition. As set forth in the referenced patent application, monitored patient threshold may be used to control the rate of delivery of stimulus signals. Also, changes in electrode construction and improvements in programmability are expected to enhance the value of threshold tracking and, more generally, the value of being able to continuously monitor both evoked and natural heartbeat signals.
While the utility of the subject invention is best described in the pacemaker, or pacing system embodiment, it is to be understood that the invention has utility in other systems for physiological stimulation. The invention may be practiced in any application where it is desired to quickly determine the physiological response to an applied stimulus by detection of the resulting evoked electrical characteristic at the location of applied stimulus.